Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SEVELAMER CARBONATE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
SEVELAMER CARBONATE
180Tablet Tablets; 30Tablet Tablets; 270Tablet Tablets; 30Tablet Tablets; 180Tablet Tablets; 270Tablet Tablets
Genzyme Ireland Limited
Consumer Medication Information Leaflet (RiMUP) 1 RENVELA ® FILM-COATED TABLETS Sevelamer Carbonate 800mg What is in this leaflet 1. What Renvela is used for 2. How Renvela works 3. Before you use Renvela 4. How to use Renvela 5. While you are using it 6. Side effects 7. Storage and Disposal of Renvela 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number What Renvela is used for Renvela is used for patients who have kidneys that do not work properly are not able to control the level of serum phosphorus in their blood. The amount of phosphate then rises (your doctor will call this hyperphosphataemia). Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits is can stiffen your blood vessels and make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures. How Renvela works Renvela contains sevelamer carbonate as the active ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood. Before you use Renvela When you must not use it Do not take Renvela if: • You are allergic (hypersensitive) to sevelamer carbonate, sevelamer hydrochloride, or to any of the other ingredients of this medicine (listed in Section 8 below). -Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • You have bowel obstruction. Before you start to use it Check with your doctor before taking Renvela if: • You have swallowing problems • You have problems related with motility (movement) in your stomach and bowel • You are being sick frequently • You have active inflammation of the bowel • You have undergone major surgery on your stomach or bowel • You have severe constipation. Additional treatments: Due to either your kidney condition or your dialysis treatment you may: - develop low or high levels of calciu Citiți documentul complet
MY/REN/0422/CCDSv8 Renvela Sevelamer carbonate Tablets 800mg Revision date: Apr 2022 (CCDS V8 based on US PI Apr 2020) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Renvela safely and effectively. See full prescribing information for Renvela. Renvela (sevelamer carbonate), tablets, for oral use INDICATIONS AND USAGE Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l. Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease. DOSAGE AND ADMINISTRATION Starting dose is one or two 800 mg tablets three times per day with meals. (2) Adjust by one tablet per meal in two week intervals as needed to obtain serum phosphorus target (1.13 to 1.78 mmol/L). (2) DOSAGE FORMS AND STRENGTHS Tablets: 800 mg (3) CONTRAINDICATIONS Bowel obstruction. (4) Known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. (4) WARNINGS AND PRECAUTIONS Serious cases of dysphagia, bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery. (5.1) ADVERSE REACTIONS Most of the safety experience is with sevelamer carbonate tablets and sevelamer hydrochloride. In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%) and constipation (8%). (6.1) MY/REN/0422/CCDSv8 DRUG INTERACTIONS For oral medication where a reduct Citiți documentul complet